GCP specialist R&D Auditing Department
Chiesi
Overview
In this role you ensure GCP compliance across Global R&D by managing CAPAs, quality metrics, and audit programs. You will drive the documentation and process controls that support audit readiness and supplier qualification. You work closely with cross-functional teams to sustain a robust quality system and enable compliant clinical trials. The position offers a hybrid setup at the Parma HQ within a values-driven, sustainability-minded organization.
Retribuzione / Benefits
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- remote work options
- relocation support
Responsabilità
- Manage GCP CAPA plans and follow-up
- Coordinate collection of quality metrics and KPIs for Global R&D
- Oversee Trackwise, supplier, and audit workflows
- Support external consultants in the Auditing & Supplier Qualification Unit
- Finalize Quality Documents for the unit
- Write/Review SOPs related to audit and qualification of clinical service providers
- Provide training on relevant activities and procedures
- Ensure documentation traceability and audit report finalization
Requisiti fondamentali
- At least 3 years of experience in Pharmaceutical, Consultancy, or CRO in Quality Assurance for R&D with strong GCP knowledge
- Knowledge of GCP requirements and quality systems
- Understanding of the pharmaceutical development process supporting clinical trials
- Experience with training techniques
- Scientific degree
- Good knowledge of English
- Clear communicator
- Attention to detail
- Team collaboration
- GCP knowledge
- Quality system proficiency
- CAPA management
Offerta di lavoro pubblicata 2 giorni fa
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